Vioxx Lawsuit Help

Vioxx Side Effects

Merck has vigorously defended the way it handled their blockbuster arthritis and pain-relief drug Vioxx, saying the company acted promptly to withdraw the drug when clear scientific evidence showing Vioxx side effects presented itself. There are many critics who believe Merck continued to defend Vioxx for years despite evidence that surfaced indicating potentially deadly Vioxx side effects. Researchers have warned patients to avoid Vioxx over the years, and Public Citizen consumer group included Vioxx on its Worst Pills, Best Pills newsletter in April 2001 warning patients of Vioxx side effects.

Still, Merck continued to stand by the lucrative drug, claiming adequate scientific information on Vioxx side effects had not been present until the company’s own 3-year study was halted, which resulted in the decision to withdraw Vioxx. No longer able to deny dangerous Vioxx side effects risks, Merck was praised by the FDA for doing “the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market.” Many feel differently, saying that because the FDA and Merck allowed Vioxx to stay on the market for so many years despite known serious Vioxx side effects there is a serious deficiency in federal regulation and that large drug companies have the ability to side- step worrisome data.

Two million Americans were taking Vioxx when it was pulled, and according to estimates by Merck, approximately 20 million Americans have taken the drug. Vioxx side effects appear to have been brought to light by an FDA internal federal drug expert, but there are allegations that the FDA silenced the reports. This has resulted in greater scrutiny of the FDA and the seemingly passive role it has been accused of portraying for the last several years.

The Government Accountability Office (GAO), an investigative arm of Congress, was asked to look into the controversial handling of Vioxx after the recall was announced. An associate director for science in the FDA Drug Center’s Office of Drug Safety told Senate investigators he had faced stiff resistance within the agency when his team concluded high doses of Vioxx should not be prescribed or used because of triple the risk of Vioxx side effects like heart attacks and sudden cardiac death. Scheduled to present the Vioxx side effects findings in late August 2004, the researcher said he ran into resistance by the FDA, and according to Sen. Chuck Grassley, he was “ostracized” and “subjected to veiled threats”.

Upon approval of Vioxx, the FDA never believed Vioxx and other COX-2 inhibitors were safer than traditional NSAIDs (such as ibuprofen and naproxen), despite claims COX-2 inhibitors were less likely to cause bleeding and other digestive tract complications. The FDA still required labeling for Vioxx side effects carry the same digestive warning as the NSAIDs, so when Merck launched a trial to prove the drug was safer, the study successfully demonstrated it was safer on the digestive tract than naproxen but unexpectedly found a new Vioxx side effect instead.

The study found that when compared to patients taking naproxen, Vioxx users had double the risk of cardiovascular problems. Merck’s findings were first included in a March 2000 press release by downplaying the actual Vioxx side effects risk, saying Vioxx caused fewer digestive tract problems than naproxen and that “significantly fewer thromboembolic events (meaning heart attacks and strokes) were observed in patients taking naproxen.”

One of the more controversial aspects of the Vioxx recall is that Merck continued to argue that the study didn’t show cardiovascular Vioxx side effects, but that naproxen protected against them. Following the Vioxx recall, when the president of Merck Research Laboratories Peter Kim was asked to address allegations that the company could have pulled Merck following the early study, Kim said “th is data was of concern to us” but that a decision could not be made since a placebo was not used as a comparison. When asked why a placebo was not used, Kim responded the study was testing patients with painful rheumatoid arthritis, which would have been “medically difficult” to give placebos to them over a long time.

Due to Vioxx side effects safety concerns, the FDA ordered Merck to send doctors a letter “to correct false or misleading impressions and information” in February 2001 and required Merck to make a possible link to heart attacks and strokes on Vioxx’s label in April 2002. The Vioxx side effects concerns have been surfacing for the last couple years, hurting sales of the drug and causing controversy, despite Merck still having worldwide sales totaling $2.5 billion in 2003. Vioxx side effects of increased risk of heart attack and stroke has led to a potentially high number of people filing lawsuits for health effects suffered because of the popular drug.

For more information on Vioxx side effects, please contact us to confer with an attorney.

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